Recently approved oral antiviral drug for COVID-19, Merck’s Molnupiravir, has “major safety concerns,” said Balram Bhargava, director general of ICMR (Indian Council of Medical Research) on January 5, 2022. He added that Molnupiravir has safety concerns including teratogenicity, severe damage to the bones and muscles, and mutagenicity. Thus, it is not added in the national task-force treatment of coronavirus. With this, he confirmed that the drug has not been added by the World Health Organisation (WHO) and the UK also.
Bhargava said that the use of contraception is necessary for at least three months after administering this drug. This is because the baby born may be affected by the effects of teratogenicity of Molnupiravir. It can severely harm the child.
In medical terms, teratogenicity is the ability of a substance (medicine) to cause defects in the developing fetus inside the womb. Mutagenicity is the event that leads to a permanent genetic change (usually DNA) that can cause conditions like cancer.
Molnupiravir’s approval in the US was based on a study that included 1,433 patients. The average rate of reduction in moderate disease when administered to mild cases was 3%. However, Bhargava added, “We must remember that Molnupiravir has major safety concerns” and “the benefit was visible on 1,433 unvaccinated patients.”
He said that the experts are concerned mainly about the effects it can have on patients who are pregnant or plan to get pregnant. Other issues that remain concerning are soft tissue injury in children, the age group that is reproductive, and medical history of vaccinations and infections. “As of now, Molnupiravir is not a part of the treatment and the experts are going to discuss it again,” Balram Bhargava added.
After Merck, Dr. Reddy’s Laboratories plans to launch the generic version of this drug with 10 capsules per strip under the brand name Molflu. As per the reports, it will be priced at ₹35 per capsule. Further, it is expected to be available in the country from early next week.